Recruiting

Cellworks Singula™ & Ventura™

Sponsor:

Avera McKennan Hospital & University Health Center

Code:

NCT05308784

Conditions

Pan-cancer

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Cellworks Singula and Ventura reports

Study Details

Brief summary:

The purpose of this study is to determine the benefit of Cellworks Singula™ and Ventura™ reports on physician and molecular tumor board treatment recommendations across a large set of pan-cancer indications. Cellworks reports aim to provide NGS-based therapy recommendations to aid the decision-making of patients, physicians, and molecular tumor boards.

Conditions

Pan-cancer

Study ID

NCT05308784

Start date

Jan 1, 2022

Status verified date

Jul, 2023

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

1. Have any stage of cancer for the indications listed at: https://cellworks.life/mycare101 Patients are eligible at any stage of disease.
2. Expected to be alive 6 months or more
3. Requirements for NGS testing (e.g., panel or whole-exome sequencing): NGS testing has been ordered from or performed by one or more vendors specified at: https://cellworks.life/mycare101 . NGS reports must be ordered or performed within the last 90 days. Cellworks will accept all NGS input formats available, including PDF, VCF, BAM, and FastQ.
4. Requirements for additional laboratory testing If Hematological Indication, Cytogenetics in the form of FISH, Karyotyping, IHC, and/or aCGH has been ordered If Acute Myeloid Leukemia (AML), FLT3-itd testing has been ordered If Indication is a form of Brain Cancer (e.g., glioblastoma), Cytogenetics in the form of FISH, Karyotyping, IHC, and/or aCGH has been ordered and MGMT Methylation test has been ordered

Study Design

Enrollment

730 participants

Anticipated

Interventions and Outcome Measures

Interventions

Cellworks Singula and Ventura reports

Personalized drug match reports based on patients' genomic aberration.

Primary outcome measure

  • Physician satisfaction on Cellworks reports [ Time Frame: 2022.1 - 2023.1 ]

Central Contacts and Locations

Central contacts

Tobias Meissner, PhD

605-322-3894tobias.meissner@avera.org

Locations

Avera McKennan

Recruiting

Sioux Falls, South Dakota, United States, 57105

Contacts

Tobias Meissner, PhD

605-322-3894tobias.meissner@avera.org

More Information

Sponsor

Avera McKennan Hospital & University Health Center

Last update posted

Jul 19, 2023

Last verified

Jul, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Avera McKennan Hospital & University Health Center on 2023-07-19.